Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Primary Purpose
Diabetic Autonomic Neuropathy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Quinapril
Sponsored by
About this trial
This is an interventional trial for Diabetic Autonomic Neuropathy
Eligibility Criteria
Inclusion Criteria:
- Diabetes mellitus with both autonomic and peripheral neuropathy
Exclusion Criteria:
- Hypertension, coronary heart disease
Sites / Locations
Outcomes
Primary Outcome Measures
Changes in R-R variation during deep breathing
Changes in response to Valsalva maneuver
Changes in 30:15 ratio
Changes in blood pressure response to standing
Secondary Outcome Measures
Full Information
NCT ID
NCT03031834
First Posted
January 12, 2017
Last Updated
January 24, 2017
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT03031834
Brief Title
Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Official Title
Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
May 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
5. Study Description
Brief Summary
Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Autonomic Neuropathy
7. Study Design
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quinapril
Primary Outcome Measure Information:
Title
Changes in R-R variation during deep breathing
Time Frame
2 years
Title
Changes in response to Valsalva maneuver
Time Frame
2 years
Title
Changes in 30:15 ratio
Time Frame
2 years
Title
Changes in blood pressure response to standing
Time Frame
2 years
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
Diabetes mellitus with both autonomic and peripheral neuropathy
Exclusion Criteria:
Hypertension, coronary heart disease
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
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